A Phase I/II Clinical Trial of Temsirolimus plus Neratinib for Subjects with Metastatic HER2-Amplified or Triple-Negative Breast Cancer

Full Title
A Phase I/II Trial of Temsirolimus plus Neratinib for Subjects with Metastatic HER2-Amplified or Triple Negative Breast Cancer

Trastuzumab is commonly used to treat women with breast cancers that produce large amounts of the HER2 protein. However, in some women, the breast cancer continues to grow despite trastuzumab therapy.

In this study, researchers are evaluating the safety and effectiveness of combining two drugs, neratinib and temsirolimus, in women with HER2-positive breast cancer that persists despite prior trastuzumab therapy. Women with triple-negative breast cancer will also be part of this study. These cancers do not express HER2 nor contain estrogen or progesterone receptors, and women with these cancers have limited treatment options.

Neratinib is an investigational drug that blocks some of the functions of the HER2 protein, and has been shown to be effective in HER2-positive cancers that have grown while on trastuzumab therapy. Temsirolimus is approved for the treatment of advanced kidney cancer, but its use in breast cancer is considered investigational. It works on another protein called mTOR that HER2 stimulates.


To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Patients must have HER2-positive breast cancer that has progressed despite trastuzumab and/or lapatinib therapy, OR they must have triple-negative breast cancer.
  • Patients must consent to biopsy of the cancer to facilitate laboratory studies attempting to understand the causes of resistance to therapies such as trastuzumab.
  • At least 14 days must have passed since completion of prior trastuzumab or lapatinib therapy and receipt of the study drugs.
  • Patients participating in the phase I portion of the study may have had any number of prior chemotherapy regimens for advanced disease, but patients participating in the phase II portion may not have had more than four prior chemotherapy regimens.
  • Patients must be able to be ambulatory for more than half of their normal waking hours.
  • Patients must be age 18 or older.

For more information about this study and to inquire about eligibility, please contact Dr. Sarat Chandarlapaty at 212-639-5449.

Breast Cancer
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